In our latest blog, Chris Yates, President of Abingdon Health USA Inc, explains why European in vitro diagnostic (IVD) device manufacturers can no longer treat the US as an export-only market, and how a dual-site manufacturing strategy protects against tariff uncertainty, unlocks procurement access, and positions your products for long-term commercial success in the world’s largest diagnostics market.
For European diagnostics companies, the United States has always been the biggest commercial prize. It remains the world’s largest IVD market, with the highest reimbursement rates, the deepest venture funding ecosystem, and the most established regulatory pathway for bringing new tests to market.
But designing for the US market and manufacturing for the US market are increasingly two different matters. A series of converging forces: tariff volatility, domestic procurement preferences, supply chain resilience requirements; and the growing political momentum behind “Made in America” are making it significantly harder for European-manufactured diagnostics to compete on equal terms with domestically produced products. For companies that are serious about the US market, the question is no longer whether to establish US manufacturing capability, but how to do it without abandoning the European operations that serve the rest of their global business.
The Forces Driving the Shift
Tariff uncertainty is the most immediate pressure. US trade policy has become increasingly unpredictable, with tariff rates on imported diagnostics shifting between administrations and sometimes within them. European manufacturers currently face tariff rates that vary significantly depending on product classification, country of origin, and the political environment of the moment. For companies building multi-year commercial plans, this uncertainty makes it extremely difficult to forecast landed costs, set pricing, and protect margins.
Federal and state procurement preferences add a second layer of pressure. Government-funded programs, particularly those supported by BARDA, NIH, and the Department of Defense, increasingly favour or mandate domestically manufactured products. For European companies bidding on US contracts, the absence of domestic manufacturing capability is becoming a disqualifying factor rather than a minor disadvantage.
The broader “Made in America” movement extends beyond government procurement. Post-pandemic awareness of supply chain fragility has created genuine market preference for domestically manufactured health products. Distributors and health systems are actively seeking suppliers who can guarantee US-based production. And it’s not only about being “Made in America”, it’s also about having a US domestic supply chain in place, so reagents and components are “Procured in America,” where possible. Supply chain traceability can really impact projects and we have seen grants withdrawn (with the potential for financial penalties) where the risk from an overseas supply chain is deemed too high.
Why Dual-Site, Not Relocation
The answer is not to abandon European manufacturing and relocate. That would sacrifice proximity to European and Asian markets and potentially compromise CE-IVDR compliance.
The answer is a dual-site manufacturing strategy: maintain European production for markets where it serves best, while adding US-based manufacturing to serve the US.
This approach delivers three advantages:
- tariff insulation, since products manufactured in the US for the US market eliminate import duties entirely;
- procurement access, since domestically manufactured products qualify for contracts requiring US production; and
- supply chain resilience, since disruption at one site does not compromise supply to the other’s regional markets.
Choosing a US Manufacturing Partner: Key Considerations
Establishing US manufacturing does not require building your own facility. Contract manufacturing through an experienced US-based CDMO is faster, lower risk, and more capital-efficient. But the choice of manufacturing partner will determine whether your dual-site strategy delivers on its promise or creates new problems. Several factors should guide your decision:
Technical transfer expertise is the first priority. Moving a validated lateral flow manufacturing process from a European facility to a US site is a complex undertaking. Equipment differences, raw material sourcing variations, environmental conditions, and regulatory documentation requirements all need systematic management. Your US manufacturing partner must have specifically demonstrated experience in receiving technical transfers for lateral flow products.
Supply chain expertise and development capabilities are also essential. There may be a need to re-engineer an existing product to swap key reagents if the current source doesn’t meet the procurement traceability criteria. Having a knowledgeable supply chain team involved in that detailed review is fundamental to identify challenges and provide alternatives. An experienced CDMO’s R&D team can also support in the development work to make the required changes.
Regulatory capability across both FDA and CE-IVDR is not optional. A dual-site strategy means maintaining compliance in two regulatory jurisdictions simultaneously. Your US partner should understand not only FDA 510(k) and PMA requirements, but also how manufacturing changes affect your European regulatory filings. Manufacturing changes made for the US site may trigger variations under CE-IVDR and a partner who understands both frameworks can navigate these interdependencies, rather than creating regulatory problems while solving manufacturing ones.
Scalability and flexibility matter more than initial capacity. Your US manufacturing volumes may start modestly and grow as you win contracts and build market share. A partner who can scale production in response to demand and grow with you without requiring you to commit to minimum volumes that exceed your initial commercial trajectory, provides the flexibility that a new market entry demands.
Finally, consider whether your US partner can support the full product lifecycle, not just manufacturing. Scale-up optimisation, process validation, stability studies, post market surveillance, reagent and component supply changes, and ongoing quality management all benefit from being managed by a partner who understands the complexities of your product. A CDMO offering integrated services across the full lifecycle reduces the time and cost associated with managing multiple vendors across two continents.
Making It Work
The European diagnostics companies that will thrive in the US market over the next decade are those establishing dual-site manufacturing capability now, before tariff escalation or procurement requirements force their hand. The companies that wait will find themselves making the same transition under time pressure, at higher cost, and with fewer partner options.
A well-chosen US manufacturing partner makes the transition manageable. The right partner brings lateral flow-specific technical transfer expertise, regulatory knowledge spanning both FDA and CE-IVDR, and the manufacturing flexibility to grow alongside your US commercial ambitions. The result is a manufacturing strategy that protects your European business while unlocking the full potential of the American market.
About Abingdon Health: Abingdon Health provides integrated lateral flow development, technical transfer, regulatory consultancy, and commercial manufacturing services from facilities in Madison, Wisconsin, USA; Doncaster, UK; and York, UK. Our US manufacturing site in Madison launches in July 2026, providing scale-up, technical transfer, and commercial manufacturing capability purpose-built for lateral flow production. Combined with our established UK development and manufacturing operations, we offer European and US diagnostics companies true dual-site development and manufacturing partnership, with unrivalled expertise in lateral flow technical transfer and regulatory compliance across FDA and CE-IVDR. Get in touch with Abingdon Health to explore how our dual-site capability can strengthen your US market strategy.
